Transporting Infectious Substances Flashcards
Which US Department and regulations govern shipment of infectious material?
Infectious substance is regulated as a hazardous material under US Department of Transportation (DOT) Hazardous Material Regulations (HMR)
What are the Hazardous Material Regulations?
HMR applies to any material DOT determines is capable of posing an unreasonable risk to health, safety and property when transported in commerce
Infectious substance must conform to HMR requirements when transported by air, highway, rail or water
Who provides international regulations for transport of infectious substances?
Recommendations made by the Committee of Experts on the Transport of Dangerous Goods (UNCETDG)
committee of the United Nations Economic and Social Council
Presented in form of Model Regulations
Are US classification criteria and packaging requirements similar to international standards?
US criteria and packaging requirements are consistent with international standards
promotes compliance and ensures safety for transportation of infectious substances
How are infectious substances defined in terms of transportation?
Substances that are known or reasonably expected to contain pathogens
Pathogens are microorganisms and other agents which can cause disease in humans or animals
What are the new HMR requirements?
Two-tiere classification system : categories A and B
What is HMR Category A
Infectious substance in form capable of causing PERMANENT disability or LIFE-THREATENING or FATAL disease in otherwise healthy humans or animals when exposure to it occurs
Exposure occurs when substance is released outside of its protective packaging resulting in physical contact with humans or animals
Classification based on known medical history or symptoms of source patient/animal, endemic local conditions or professional judgment concerning invidicual circumstances of source
Which HMR category poses the highest risk?
Category A
What is HMR Category B?
Infectious substance not in form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure occurs
includes Category B infectious substances transported for diagnostic or investigational purposes
What are some examples of substances not subject to packaging and shipping requirements?
blood, plasma, blood components collected for purpose of blood transfusion
preparation of blood products sent for testing as part of collection process except if person collecting has reason to believe it contains infectious substance
Dried blood spots, specimens for fecal occult blood detection placed on absorbent filter paper or other material
Category B substance contained in patient sample being transported for research, diagnosis, investigational activities or disease treatment or prevention or biological product when transported by PRIVATE or CONTRACT COURIER in MOTOR VEHICLE used EXCLUSIVELY TO TRANSPORT SUCH MATERIALS
Patient specimens for which there is minimal likelihood that pathogens are present if transported in packaging that prevents any leakage and is marked with “Exempt Human Specimen”
What is exempt human specimen and what are the 3 packaging requirements?
Patient specimens in which there is minimal likelihood that pathogens are present
3 Requirements:
-Leak-proof primary receptacle
-leak-proof secondary packaging
-Outer packaging of adequate strength for capacity, mass and intended use and one surface having minimum dimensions 100mm x 100mm
For liquids, absorbent material in sufficient quantity to absorb the entire contents should be placed between primary receptacle and secondary packaging. Any leak of liquid should not reach outer packaging and not compromise integrity of cushioning material
Multiple fragile primary receptacles should be individually wrapped or separated to prevent contact between them
What are some examples of exempt substances?
Blood or urine tests to monitor cholesterol, glucose, hormones, prostate-specific antigen
tests to monitor organ function for humans with non-infectious diseases
therapeutic drug monitoring
insurance or employment screening tests
pregnancy test
biopsies to detect cancer
antibody detection in absence of any concern for infection (autoimmune disease or vaccine-induced immunity)
What is a biological product?
virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product, or arsphenamine or derivative of arsphenamine or trivalent arsenic compound… applicable to the prevention, treatment, or cure of a disease of humans and animals
what is a culture?
infectious substance containing a pathogen that is intentionally propagated
does NOT include human or animal patient specimen
What is a patient specimen?
human or animal materials collected directly and transported for RESEARCH, DIAGNOSIS, INVESTIGATION, DISEASE TREATMENT or PREVENTION
includes excreta, secret, blood, tissue, swabs, body parts and specimens in transport media
